WASHINGTON (Reuters) - Silicone breast implants will be widely available in the United States for the first time in 14 years after U.S. health officials approved sales by two companies on Friday.
Mentor Corp. and Allergan Inc. each must study the implant risks in 40,000 women for 10 years, the Food and Drug Administration said. Silicone breast implants were banned for most U.S. women in 1992 after some complained the devices leaked and made them chronically ill.
FDA officials said the companies had provided “reasonable assurance of the benefits and risks” that would enable women to make informed decisions.
“We now have a good understanding of what complications can occur and at what rates. We also know that women who get these devices will probably need to have additional breast implant surgery at least once,” said Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health.
Breast pain, hardening of the area around the implant, change in nipple sensation, implant rupture and the need for additional surgery all were reported in the companies’ studies, the FDA said. Still, most women said they were happy with the implants.
Mentor’s data tracked women with implants for about three years, while Allergan’s followed women for four years, the FDA said.
Independent research over the past decade has found no convincing evidence that breast implants were associated with connective tissue diseases or cancer, the FDA said. The manufacturers’ post-approval studies are expected to further examine those issues.
Opponents criticized the FDA approval, saying complications were likely for most women and long-term risks were unknown.
“The FDA’s standards for implants has reached a new low with this decision,” said Diana Zuckerman, president of the National Research Center for Women & Families.
Zuckerman added that the FDA “has an absolutely terrible track record in terms of enforcing post-market studies.”
Rep. Rosa DeLauro, a Connecticut Democrat on the House Appropriations Committee, said the approval “appears to be yet another example of the FDA dismissing scientific evidence in order to appease corporate interests.”
“When Congress reconvenes next session, it must examine the agency’s approval process and ensure that the FDA makes decisions based on science and not on corporate and political considerations,” DeLauro said.
The safety controversy had left saline-filled breast implants as the only option for most U.S. women since sales limits were put in place in 1992. Silicone versions had been available only through research studies for cancer survivors and others needing reconstruction or implant replacements.
Plastic surgeons say women prefer the silicone ones.
“They feel natural. They look more natural,” said Dr. Scott Spear, an Allergan consultant and chairman of plastic surgery at Georgetown University School of Medicine in Washington.
Silicone implants were approved for cosmetic use in women ages 22 and older and for breast reconstruction in women of all ages.
The FDA said most implant ruptures cause no symptoms and therefore women would need regular MRI exams to see if their devices remained intact. “The cost of MRI screening over a woman’s lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance,” the FDA said.
Silicone breast implants are among the most extensively studied medical devices, the FDA’s Schultz said.
Allergan President Michael Ball said “science has prevailed” in the FDA approval, which would give U.S. women the same options others around the world had for years.
Allergan’s saline and silicone breast implant sales were about $230 million globally in 2005, Ball said. The silicone approval should lead to double-digit growth of the market, he said.
Mentor Chief Executive Joshua Levine said in a statement the approval was “a historic moment” for the company but he did not provide sales estimates.
The FDA posted information about silicone implants here
Additional reporting by Susan Heavey